Update: November 8 2019 — Cassiopea announces US FDA reviewing new drug application (NDA) for clascoterone cream 1% to treat acne.
I have covered Italian company Cassiopea numerous times on this blog. Primarily due to its Breezula topical product for male pattern hair loss. Earlier this year, Cassiopea announced very good 12-month Phase 2 clinical trial results for Breezula.
Clascoterone, Winlevi and Acne
Cassiopea is also working on an acne product called Winlevi. Both Breezula and Winlevi are based on the same key ingredient: Clascoterone. However, the dosage in Winlevi is significantly lower at 1%. Winlevi is almost ready to come to market per Cassiopea’s product pipeline.
Earlier this week, Cassiopea made a major announcement. The company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking marketing approval for clascoterone cream 1% for the treatment of acne.
Some interesting points in the press release and my thoughts:
Clascoterone cream 1% targets androgen receptors at the site of application. This inhibits the local (skin) effects of dihydrotestosterone (DHT). Apparently, DHT is a key driver of acne lesion development. Most people wrongly assume it is solely testosterone.
This acne treatment product will be safe to use in both males and females.
If approved, clascoterone cream 1% will represent the first new mechanism of action in the treatment of acne in almost 40 years. Interestingly, if Breezula is approved for hair loss in 2021, it will be the first new topical or oral treatment for hair loss in almost 25 years.
I have covered Italian company Cassiopea since 2014 (when it was called Cosmo Pharmaceuticals). The company is developing a topical anti-androgen hair loss product named Breezula (originally called CB-03-01). The chemical name for this product is Clascoterone.
Breezula will be available for both men and women. Several of my well known physician contacts in the hair loss world have told me great things about this product. Their feedback is based on what they saw at conferences or heard from colleagues.
Breezula Phase II Trials Very Successful
In July of last year, Cassiopea stated that the interim Phase II clinical trial results for Breezula were very positive. Today, they released twelve month Phase II trial results with the same conclusion:
The presentation of the results is confusing, detailed, full of acronyms and somewhat open to interpretation. Note that “BID” in there stands for “twice per day” after conversion from Latin. Hopefully they release before and after photos at some point.
Also note that the previous 6-month interim report had 375 subjects, and the 12-month report has 344 subjects. The trial was conducted in Germany.
Breezula Target Area Hair Count Increase
Best case result highlighted in yellow (14.3 new hairs per square centimeter after 12 months of 7.5% BID dosage):
Breezula Target Area Hair Width Increase
Best case result highlighted in yellow (762.5 um width increase after 12 months of 7.5% BID dosage):
My gut feeling is that Breezula will be at least as effective as Finasteride and Minoxidil.
Some key points from the above linked article from Cassiopea:
If approved, Breezula (Clascoterone) will be the first FDA-approved topical anti-androgen for the treatment of androgenetic alopecia.
Moreover, it would also be the first new drug approved for treating androgenetic alopecia since 1997. That year was when Propecia (aka Finasteride) was first approved to treat hair loss. That year was also when Tiger Woods last won the Master’s before this past weekend’s surprise.
Based on these great results, Cassiopea plans to proceed with 6-month Phase III trials in men in the fourth quarter of 2019, after consultation with the FDA. The company is also going to start proof-of-concept trials in women.
Breezula works by blocking dihydrotestosterone (DHT) interaction with hair follicle androgen receptors.
Clascoterone does not interfere with testosterone and other hormones in male subjects. Libido and sexual behavior changes have so far not been observed in clinical trials. Moreover, due to its rapid metabolism and localized activity, Clascoterone (Breezula) does not produce any systemic side effects.
In the past, I used to often state that perhaps an initial cure for hair loss would entail the usage of a cocktail of products. Each working via different mechanisms and chemical or biological reactions.
It is looking likely that Breezula will be one of the main products in this cocktail.
Note that Clascoterone cream to treat acne will be released by Cassiopea before Breezula. The acne product is called Winlevi.